Anavex Life Sciences Corp (AVXL)

[imho]

The safest path for Anavex would be to have a second phase 3 going for AD. However, there are two possible pathways to get by with the results of the 2b/3 only (which should satisfy the FDA for a phase 3 pivotal study if results are good). Missling is hoping that Rett is approved (or in mid 2022 have great results for Excellence implying likelihood of approval is high). If so, then they could submit an NDA for A273 for AD with one phase 3 (as the FDA often requires only one phase 3 for a drug already approved for a different indication). This path will work if the FDA does not have a problem with the different age categories. A second path to get approval with one phase 3 is the Accelerated Approval pathway that the FDA surprised us with in the case of Aduhelm. To get this approval the FDA will need to accept the S1R mRNA data as a biomarker. This is no small feat and the second path is riskier than the first.

Good perspective. I agree.

IMHO